Page contents

Several news sources have today reported that codeine-based pain killers sold over the counter can “cause addiction within three days”, and that new rules will change the way they will be made available. These changes include adding addiction warnings to packaging, and changing the conditions for which they can be recommended.

What is the basis for these current reports?

These current reports are based on a press release issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the government agency responsible for ensuring that medicines and medical devices are effective and safe. The press release highlights upcoming changes to the way that certain prescription and over-the-counter medications can be made available to the public. These changes are based on the policy of the government and the MHRA.

The MHRA has announced that manufacturers and dispensers of some common painkillers containing codeine (a weak opioid drug) will need to change their practices in order to minimise the risk of over-use and addiction. These measures include improved labelling, changing quantities that can be purchased, and making certain medicines available only on prescription.

What measures are being proposed?

The MHRA has announced a package of measures in line with the government’s change of policy. These include:

A change in some medications’ indication (i.e. what the drugs are recommended for) to remove references to colds, flu, coughs, sore throats and minor pain. This will also add a clarification that these types of medicines should be used for short-term treatment of acute or moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.

Clear information on the labelling and in the patient information leaflets that come with the medications. These will include warnings that the products are for short-term use only (up to three days) and that overuse can lead to addiction or ‘overuse headache’.

Manufacturers will need to display on the front of the pack the specific warning: "Can cause addiction. For three days use only".

Packs containing more than 32 tablets (including water-soluble effervescent formulations) will not be available over the counter.

Advertising for the products must be updated to reflect the new indications and warnings. Advertisers will not be allowed to refer to the painkilling power and strength of the drugs, and adverts should include the statement ‘Can cause addiction. For three days use only’.

What is codeine?

Codeine is a weak opioid painkiller (analgesic). Opioids are a group of drugs used to treat moderate and severe pain that cannot be relieved by more simple analgesics, such as paracetamol. Other stronger opioids are used in hospital practice for various types of pain relief, including morphine, diamorphine (heroin), pethidine and tramadol.

A range of over-the-counter painkillers contain codeine, including Nurofen Plus and Co-codamol. Usually, these drug preparations will contain codeine combined with other analgesics, such as paracetamol, aspirin or ibuprofen, and possibly other drugs, such as caffeine, decongestants or anti-sickness drugs (depending on the branded medication’s indicated use).

Although effective for reducing pain, opioids have a range of side effects that vary in severity, depending on the strength and dose of the drug. The most common side-effect experienced with a mild opioid such as codeine would be constipation. There are also several medical conditions and population groups in which opioids should be used with caution, such as the elderly, debilitated people, and people with certain types of kidney, lung or bowel diseases.

While codeine is sometimes used to treat mild pain, the new recommendations call for it to be used only for acute, moderate pain that cannot be relieved by either paracetamol, aspirin or ibuprofen alone.

What is the evidence that codeine is addictive?

The evidence on codeine drug dependency has been discussed by an All-Party Parliamentary Drugs Misuse Group, which conducted a year-long inquiry into physical dependence and addiction to prescription and over-the-counter medication that concluded in January 2009. It gathered evidence from a wide range of stakeholders including the general public, medical and addiction specialists, pharmaceutical companies, regulatory bodies and charities. The review has been discussed in Parliament, and the recommendations reflected in the government’s review are also in line with those of the MHRA.

How does this new advice affect me?

The new recommendations and changes will not affect people taking prescription pain killers. People who purchase over-the-counter pain killers containing codeine will notice changes to their medication’s labelling and specified indications from next year, when manufacturers and dispensers will implement the new policies.

Codeine-based drugs can be effective if used appropriately, but there are risks associated with using them for longer than three days. It is important that people who buy pain killers over-the-counter follow the new advice, which is based on the available evidence on potential dependency.

People are advised to always read drug labelling, noting in particular what drug preparations are contained within the branded medication, and following recommendations for use. Those who have concerns about their use of painkillers should speak to the pharmacist or doctor. Those who experience ongoing pain and feel the need to take analgesics on a regular basis should also seek medical advice.